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INOSIDEX study: to determine whether the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women

A randomised trial to determine whether the the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74096908
Enrollment
155
Registered
2013-01-04
Start date
2011-10-16
Completion date
Unknown
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimum control of insulin resistance and lipid profile in post-menopausal women Nutritional, Metabolic, Endocrine

Interventions

The study has involved 155 postmenopausal women with metabolic syndrome recruited at visit for clinical-instrumental surveillance program for breast cancer prevention within National Cancer Institute

Sponsors

Pharma Dancan s.r.l. (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Post-menopausal women affected by metabolic syndrome at any age participating to our clinical-instrumental program of surveillance for breast cancer prevention 2. Willing to be assigned to any of the study intervention groups

Exclusion criteria

Exclusion criteria: 1. Women taking oral hypoglycemic drugs or insulin 2. Women taking statins

Design outcomes

Primary

MeasureTime frame
1. Reduction of more than 20% of HOMA-IR index and of triglycerides 2. Improvement of high density lipoprotein cholesterol 3. Reduction of anthropometric features such as body mass index, waist and hip ratio Measured at at baseline and at six months.

Secondary

MeasureTime frame
Good control of metabolic syndrome helping diet results with insulin sensitizing supplements

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026